1996년도 제35차 대한소화기학회 추계학술대회 / 일반연제 : 위장관 ; 비궤양성소화불량환자에서 위배출시간지연과 자율신경기능실조의 임상적 의의

박수헌,김진일,나종순,채현석,김재광,한준열,최규용,정인식,정규원,선희식,박두호,손형선 ( Soo Heon Park,Jin Il Kim,Jon Soon Na,Hiun Suk Chae,Jae Kwang Kim,Jun Yul Han,Kyu Yong Choi,In Sik Chung,Kyu Won Chung,Hee Sik Sun,Doo Ho Park,Hyung Su 대한소화기학회 1996 대한소화기학회지 Vol.28 No.1

미연방 정부의 자금지원을 통한 인간배아줄기세포연구의 규제

박수헌(Park, Soo-Hun) 한국토지공법학회 2009 土地公法硏究 Vol.44 No.-

인간배아줄기세포(human Embryonic Stem Cell, hES Cell)는 인류의 가장 두려운 질병(소아 당뇨, 알츠하이머, 파킨슨, 척수손상 등)을 치료할 수 있는 무한한 잠재성을 가지기 때문에 불치병으로 절망에 빠진 수 많은 환자들에게 치유가능성을 열어주는 희망의 불빛이라 할 수 있겠다. 반면에, 인간배아줄기세포주를 수립하기 위해서는 인간배아를 파괴하여야 하기 때문에 이것이 생명체의 파괴가 아닌가 하는 심각한 윤리적 문제를 야기하기도 한다. 그럼에도 불구하고, 인간배아줄기세포는 병의 근원 치료 및 환자 맞춤 치료를 가능케 하므로 미래 의료산업 변화의 원동력이 될 수 있기 때문에, 그 주도권을 확보하기 위해 정부차원이든 민간차원이든 막대한 자금지원을 통하여 인간배아줄기세포에 관한 연구는 전세계적으로 활발히 이루어지고 있다. 미국의 경우, 인간배아줄기세포연구에 관한 연방정부의 자금지원 정책은 많은 변화를 겪었고, 올해 3월 오바마 대통령이 인간배아줄기세포연구에 연방정부의 자금지원을 허용하는 대통령령을 전격적으로 발표하였다. 이에 따라, 한 해 약 30억 달러(한화 약 40조원)의 연구비를 집행하는 국립보건원이 인간배아줄기세포연구에 발벗고 나서게 되어 전 세계 줄기세포 연구에 판도의 변화를 예고하였다. 연방정부의 자금지원은 인간배아줄기세포연구의 성공에 핵심적 요소이다. 왜냐하면, 정부의 자금지원을 받음으로써 연구자는 지속적 연구수행을 통하여 연구범위를 확장할 수 있고정부의 자금지원 하에서 얻어진 연구업적은 이미 정부의 승인도장을 받아 대외적 신뢰도를 구축하여 단번에 기술(이전)의 선두그룹에 합류할 수 있기 때문이다. 또한, 연방정부는 자금지원을 통하여 인간배아줄기세포연구에 대한 적절한 통제권을 행사할 수도 있다. 이 논문은 인간배아줄기세포연구에 관한 미연방 정부의 자금지원의 중요성과 그에 관한 정책 변화를 고찰하고, 인간배아줄기세포연구에 있어서 ‘잃어버린 8년’을 만회하려는 오바마 행정부의 노력을 검토한다. 그럼으로써, 미연방 정부의 자금지원을 통한 인간배아줄기세포연구의 규제가 우리에게 줄 수 있는 시사점도 제시하고자 한다. The research of human embryonic stem cells(“hES Cells”) has an enormous potential to develope medical treatments for the mankind's most abhorred diseases on one hand. At the same time, it could raise severe ethical concerns by destroying human embryo in the process of creating hES Cell lines on the other hand. Regardless of these contradictory arguments on hES Cells, however, huge amount of money is invested to the research of hES Cells worldwidely in order to get the initiatives in this area as it could be the source of change in the future medical industry. Most of all, federal funding is crucial to the success of hES Cell research in two ways, pragmatically and symbolically. In addition, the government could also increase its control over hES Cell research when in provides federal funding. Therefore, this article explores how the U.S. government has taken steps on funding hES Cell research by examining the policies of it. Part II of this article explains what a hES Cell is, examines the benefits of hES Cell research, and outlines the ethical issues surrounding hES Cell research. Part III explains the importance of federal funding in hES Cell research in three aspects - pragmatic, symbolic, and government's control aspects. Part IV explores the policies of the federal government before President Bush's TV address on August 9, 2001. The establishments and functions of EAB, HERP, and NIH guideline are described here. Part V examines President Bush's TV address on August 9, 2001. The meaning of it, the hES Cell lines that could be the objectives of federal funding, the contents of it, and the drawbacks of it would be considered here. Part VI explores the Executive Order issued by President Obama on March 9, 2009. The meaning of it, the contents of it, and the effects of it would be described here. Finally, Part VII concludes that the changed federal funding policy of the U.S. government by regarding hES Cell treatments as future gold mine of medical industry will also give enormous impacts on the world market of medical industry by funding federal money to hES Cell research. On top of that, I expect that the change of the U.S. policy could give positive effects on korean government's policy of hES Cell research as well.

역류 식도염의 유지요법

박수헌 ( Soo-Heon Park ) 대한소화기학회 2005 대한소화기학회지 Vol.45 No.5

미국 헌법상 Standing 법리와 허위청구에 관한 법(False Claims Act)상의 Qui Tam 원고의 Standing 인정여부에 관한 고찰

朴秀憲(Park Su-Heon) 강원대학교 비교법학연구소 2000 江原法學 Vol.12 No.-

위에 발생한 조기 림프종

박수헌(Soo Heon Park),최명규(Myung Gyu Choi),조세현(Se Hyun Cho),한준열(Jun Yeul Han),최규용(Gyu Yong Choi),정인식(In Sik Chung),정규원(Kyu Won Chung),선희식(Hee Sik Sun),김부성(Boo Sung Kim),강창석(Chang Suck Kang) 대한소화기학회 1996 대한소화기학회지 Vol.28 No.1

A 34-year old female was admitted to St. Mary Hospital because of indigestion. E,ndoscopy showed cobble stone appearance of gastric mucosa on the antrum. Computed tomography showed normal gastric wall thickness and no evidence of lymph node enlargement. Upper gastrointestinal barium study showed poorly defined granular depressed lesion on the antrum. Gastric mucosectomy specimen showed centrocyte-like cells of small lymphocytes, collection of lymphocytes infiltrating and partially destroying isolated glands(lymphoepithelial lesion). After the gastric resection, she was diagnosed as a malignant lymphoma of mucosa-associated lymphoid tissue(MALTOMA) with submucosal infiltration. In analogy to the early gastric cancer, early gastric lymphoma is defined as a tumor with a maximum depth of infiltration extending into the submucosa. After chernotherapy with a regimen of cyclophosphamide, vincrisiine, adriamycin, bleomycin, H-lone, procabazine, she was discharged with complete remission. Hence we present a case of MALT-lymphoma wilh literature. (Korean J Gastroenterol 1996;28: 111 - 117)

위궤양환자에서 Rebamipide의 자유산소유리기제거에 의한 궤양치료효과

박수헌(Soo Heon Park),정운태(Woon Tae Jung),서정한(Jung Han Suh),정명희(Myung Hee Chung),정인식(In Sik Chung),이용찬(Yong Chan Lee),박인서(In Suh Park),송근암(Guen Am Song),양웅석(Ung Suk Yang),유종선(Jong Sun Rew),윤종만(Chong Mann 대한소화기학회 1997 대한소화기학회지 Vol.29 No.5

N/A Background/Aims: Helicobacter pylori has been shown to be an important pathogen of gastric disorder including gastritis and gastric ulcer. One of the potential toxic factors involving gastric mucosal cell injury is reactive oxidants, which are released from activated neutrophils. Rebamipide had been reported to promote mucus synthesis, mucosal prostaglandin content, and rapid ulcer healing, It has recently been reported to inhibit the production of oxygen derived free radicals from stimulated neutrophils. We conducted this study to evaluate the effects of rebamipide on gastric ulcer healing and reactive oxygen metabolite production. Methods: In this multicenter study conducted in Korea, combination treatment of rebamipide and ranitidine was compared with ranitidine alone in 108 patients with gastric ulcer patients. Pre- and post-treatment endoscopic findings and concentration of reactive oxygen metabolite produced were used to evaluate efficacy. The efficacy of rebamipide and ranitidine versus ranitidine was evaluated using endoscopy results, and tissue lipid peroxides by thiobarbituric acid and myeloperoxide concentration. Results: The percentage of ulcer size reduction was significantly higher with rebamipide and ranitidine group than with placebo and ranitidine group(size reduction: 71.5% vs 58.3% P=0.04556). The myeloperoxidase activities at ulcer margin in rebamipide and ranitidine group patients were 96.7+-13.4 unit/mg protein in baseline and 53.8+9.9 unit/mg protein in follow up (P=0.0065). The myeloperoxidase activities at ulcer margin in placebo and ranitidine group patients were 90.2+9.1 unit/mg protein in baseline and 63.1+6.7 unit/mg protein in follow up (P=0.0668). The thiobarbituric acid activities at ulcer margin in rebamipide and ranitidine group patients were 34.7+5.3 nmol of MDA/mg protein in baseline and 24.1W3.1 nmol of MDA/mg protein in follow up. The thiobarbituric acid activities at ulcer margin in placebo and ranitidine group patients were 14.8+1.5 nmol of MDA/mg protein in baseline and 24.3+2.7 nmol of MDA/mg protein in follow up (P=0.0059). The thiobarbituric acid activities at ulcer margin in H. pylori positive and negative patients were 28.1+2.1 nmol of MDA/mg protein and 25.3+4.7 nmol of MDA/mg protein, respectively. The myeloperoxidase activities at ulcer margin in H. pylori positive and negative patients were 79.9+5.3 unit/mg protein and 40.4+25.3 unit/mg protein, respectively (P=0.0001). The cumulative relapse rate was examined starting at 24 week after ulcer treatment. The rate was lower in rebamipide and ranitidine group patients, but insignificantly(19.2% vs 27.3%, P=0.0857). Conclusions: These results suggest that rebamipide promote gastric ulcer healing by decreasing reactive oxygen metabolite production in patients with gastric ulcer. (Korean J Gastroenterol 1997;29:569-578)

미국의 온라인 분쟁해결에 있어서 정부의 역할

박수헌(Park Soo-Hun) 한국토지공법학회 2005 土地公法硏究 Vol.25 No.-

Online Dispute Resolution(ODR) is a tool on the Internet to solve the disputes arising from e-commerce transactions. It can work on a speedy and cost-saving way compared to the traditional dispute resolution mechanism. Now, ODR is usually deployed in the field of B2C e-commerce transactions. As time goes by, the importance of B2C e-commerce transactions is growing rapidly. But, the disputes are also growing at the same rate. The cause of the disputes is, first of all, the distrust between the Internet merchants and the consumers. The deficit of enforcement on the dispute resolution decisions is also an impediment to B2C ODR. Although the self-regulation by private players is the principle in the B2C e-commerce transactions and B2C ODR, it has a limit to solve these problems. Then, what's the best idea to solve these problems? Perhaps, government is the right answer for that. Even though government intervention is against the Internet. Because government can build trust and assure the enforcement much better than the private players. Thus, this paper suggests three methods in order to eliminate the problems of B2C ODR by the self-regulation: First, bringing parties to use ODR. Second, building trust on ODR through the government control. Third, using cybercourt. However, these government interventions must give way to the self-regulation when it is possible to lift the problems through it. These should be only complementary methods. Because, ODR is based on the Internet, and the Internet is reluctant to be intervened by the government regulation. As a result, this paper explores the role of government in B2C ODR, and tries to find a way to enhance the use of ODR as a much more efficient tool in the world of the online disputes.

[일반논문] 미국행정법상 금반언원칙에 관한 소고

박수헌(Park Soo-Hun) 한국토지공법학회 2003 土地公法硏究 Vol.18 No.-

The person who relies on government advice has a legal protection, Vertrauenschutz, in korean administrative law. Similar protection might be expected where government is the promisor through the doctrine of promissory estoppel in american administrative law. Even though Vertrauenschutz and the doctrine of promissory estoppel are treated as having same meaning in requiring an agency to keep its own promise by our administrative law commentators, these two principles, however, have different requirements and limitations as well as objectives. First of all, Vertrauenschutz has the primary objective in pursuing the stability of promisee's legal lives. On the contrary, the doctrine of promissory estoppel has the priority in protecting the promisor. Thus, I will examine the requirements and limitations of the doctrine of promissory estoppel such as the rule of law, separation of powers, sovereign immunity, and the fiscal and managerial integrity of public programs in this article. According to this, I will give several grounds to differentiate the doctrine of promissory estoppel from Vertrauenschutz as a conclusion of the article.

유전자치료연구에 대한 미국 국립보건원(NIH)의 규제 고찰

박수헌(Park, Soo Hun) 이화여자대학교 생명의료법연구소 2015 생명윤리정책연구 Vol.9 No.2

환자 특성별 치료에 이득을 줄 수 있는 유전자치료에 대한 관심이 증가하고 그 위험에 대한 우려도 비례하여 증가함에 따라 환자 및 연구대상자를 보호하는 동시에 유전자치료연구의 필요성과 활성화에 대한 관심도 따라서 증가하게 되었다. 우리는「생명윤리및안전에관한법률」에서 유전자치료연구의 허용 요건을 엄격히 규정해 두고 있고, 유전자치료연구에 참여하는 연구대상자의 보호를 위해 인간대상연구에 규정되어 있는 일반적인 연구대상자 보호 규정이외에 추가적 보호장치를 규정해 두고 있지는 않다. 반면, 미국에서는 유전자치료연구를 수행하기 위한 허용 요건과 같은 법적 제한은 없고 국립보건원이「재조합 및 합성 핵산분자 포함 연구 가이드라인」을 통해 유전자치료연구를 규제하고 있다. 즉, 유전자치료연구에 관한 국립보건원 가이드라인은 연구활성화뿐만 아니라 연구대상자 보호를 위한 제도적 장치를 마련하고 있다. 연구의 안전성 확보를 위해 유전자치 료에 사용되는 물질의 위험성 평가에 따른 4단계 분류와 이에 따른 단계별 실험실 밀폐 조치를 통해 그리고 연구를 유형별로 6개 범주로 구분하여 각 범주별 IRB, IBC, RAC, OBA, NIH의 장 등의 심의 및 승인을 구하는 정도를 달리하고있다. 또한, 충분한 정보에 의한 동의서의 내용도 일반적인 인간대상연구의 동의서 내용에 유전자치료연구의 잠재적 위험에 따른 추가적인 사항들을 반드시 기재하여 동의를 받도록 한다. 이러한 미국의 가이드라인과 유전자치료를 확대하는 국제적 흐름에 맞추어 유전자치료연구를 위한 엄격한 허용 요건을 충족하는 경우에만 유전자치료에 관한 연구를 허용하는 현재의「생명윤리및안전에관한법률」상허용 요건을 유전자치료연구를 허용한다는 내용으로 개정할 것을 제안한다. 그리고, 유전자치료연구에 참여하는 연구대상자 보호를 위해 인간대상연구에 참여하는 연구대상자 보호에 더하여 유전자치료연구에 특유한 위험과 이득, 장기간의 추적관찰, 임신에 대한 고려, 사후부검 요청, 연구에 대한 언론 등의 관심 등에 관한 정보를 제공하는 조항을「생명윤리및안전에관한법률」상 동의서 목록에 추가해야 한다. 또한, 미국의 RAC, IBC, 공공정책포럼인 GTPC, GeMCRIS, OBA와 같은 유전자치료연구 담당 정부 부서 등과 같은 유전자치료연구의 심의의 공정성확보, 일반 공중의 참여 유도, 정보 제공, 유전자치료연구 전담 부서 설치를 통한 정부 부서 간 협동과 일반 공중과의 소통 확보 등 제도적 장치를 마련하여 유전자 치료연구의 활성화와 안전성 확보 및 연구대상자 보호에 만전을 기할 수 있도록 해야 할 것이다. The concerns on the gene therapy which gives benefits according to the characteristics of the individual patients are increasing and the risks of it are proportionally increasing as well. At the same time, the concerns on the necessity and promotion of the gene therapy research and the protection of the patients and the human subjects participating in the gene therapy research are increasing accordingly. In our Bioethics & Safety Act, there are very strict requirements to conduct the gene therapy research. In addition, there’s no provision to provide the additional safeguards for protecting the human research subjects. In contrast, there’s no restrictions in the American regulatory legislations on the gene therapy research. Rather, NIH regulates and promotes the gene therapy research under NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules by providing the safeguards on the safety of research and protecting human research subjects. In order to ensure the safety of research, the guidelines divides 6 categories according to the character of research and classifies four-tier danger group according to the assessment of risks of materials used in the research. In so doing, the research protocol should be reviewed and approved by IRB, IBC, RAC, OBA, director of NIH and the level of protecting the human research subjects would be enhanced accordingly. In addition, the rights, safety, and well-being of the human research subjects could be improved by the additional requirements on the informed consent form. According to the policy of this guidelines and the global trend to enlarge the gene therapy research, it is suggested in this article that the current requirement provision for allowing the gene therapy research in Bioethics & Safety Act should be amended such as just allowing it. And the specific information like potential risks and benefits, reproductive considerations, long-term follow-up, and request for autopsy, interest of the media and others in the research should be added to the general contents in the consent form of the human research subjects in Bioethics & Safety Act as well. Also, it is suggested that the mechanism should be established to promote the gene therapy research, to ensure the safety of it, and to protect the human subjects by cooperation and communication between governmental agencies and the general public through RAC, IBC, GTPC, GeMCRIS, OBA etc.

각국의 국가생명윤리관련위원회 규정을 통한 우리의 국가생명윤리심의위원회 개선 방안

박수헌 ( Soo Hun Park ) 안암법학회 2007 안암 법학 Vol.- No.25